A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
NCT03346122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2019-01-24
Summary
The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.
Conditions
- Healthy
Interventions
- DRUG
-
JNJ-64991524 Dose Level 1
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
- DRUG
-
JNJ-64991524 Dose Level 2
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
- DRUG
-
JNJ-64991524 Dose Level 3
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
- DRUG
-
JNJ-64991524 Dose Level 4
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
- DRUG
-
JNJ-64991524 Dose Level 5
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
- DRUG
-
JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
- DRUG
-
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
- DRUG
-
JNJ-64991524 Dose Level 7
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
- DRUG
-
JNJ-64991524 Dose Level 8
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
- DRUG
-
JNJ-64991524 Dose Level 9
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-11-15
- Primary Completion
- 2018-11-20
- Completion
- 2018-11-20
Countries
- Belgium
Study Locations
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